LSM and SSM for the Diagnosis of CSPH: a Prospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Advanced Chronic Liver Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Diagnosing and Monitoring Portal Hypertension Non-invasively Using Spleen Stiffness Measurement in Patients With Advanced Chronic Liver Disease: a Prospective Cohort Study
Overview
The goal of this observational study is to assess non-invasive tools' efficacy in predicting portal hypertension-related complications in individuals with advanced chronic liver disease. The main question it aims to answer are: \- what are the cut-off values for non-invasive tests (NITs) (including LSM, SSM) that predict the presence and occurrence of hepatic decompensation in individuals with advanced chronic liver disease? Participants will undergo regular study visits involving non-invasive tests (LSM, SSM) and assessments to monitor hepatic decompensation over the study period.
Primary outcome measures
- Number of patients diagnosed with portal hypertension using elastography techniques [Time frame: At baseline]
Secondary outcome measures (1)
- Identifying patients at high-risk of liver related events using elastography techniques [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Age above 18years old
- Advanced chronic liver disease (defined as LSM ≥ 10kPa)
- Ability to provide informed consent
Exclusion criteria
- Transjugular intrahepatic portosystemic shunt
- previous liver transplantation
- Abnormality of the porto-mesenteric system (portal vein thrombosis, splenic vein thrombosis, splenectomy, portal cavernomatous transformation, porto-caval shunts)
- Hematological malignancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- McGill University Health Centre — Montreal
Identifiers
NCT: NCT06181409 · MP-2022-8165